Comparison of Proton and Photon Radiotherapy of Brain Tumors: Efficiency and Side Effects in Clinical Standard Doses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 555
- 试验地点
- 4
- 主要终点
- late toxicity as cumulative measure
研究概览
简要总结
This protocol compares the toxicity of radiotherapy or radiochemotherapy applied with different radiation modalities - protons or photons. Patients with different kinds of brain tumours and foreseen high-dose radiotherapy can be included. The hypothesis of the trial is that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after proton compared to photon treatment.
详细描述
Non-randomised 2-arm phase II trial on comparison of proton versus photon radiotherapy in brain tumours using standard doses and standard combined chemotherapy protocols. Patients are assigned to the treatment groups by their own choice or availability of the treatment. Patients are stratified into 4 groups, (1) supratentorial grad III/ IV tumours without pre-irradiation; (2) supratentorial grade I/II tumours without pre-irradiation; (3) infratentorial tumours without pre-irradiation; (4) patients with pre-irradiation >40 Gy in the tumour area. Radiotherapy doses of 54-60 Gy(RBE) are applied in group 1-3 using normal fractionated schedules. In group 4, 30 Gy(RBE)/ 5 Gy(RBE) per fraction or 36 Gy(RBE) with 2 Gy(RBE) per fraction are allowed. Primary endpoint is chronic toxicity and quality of life. The hypothesis of the trial is that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after proton compared to photon treatment. Events for chronic toxicity are toxicities observed later than 3 months after end of radiotherapy and scored CTC-AE4.0 >grade 2 or a decrease in Quality of life by >10% (EORTC-QLQ C30 and BN20) or a decrease in neuropsychological functioning by >10% (MoCa test). All statistical calculations apply to group (1), i.e. supratentorial grade II/IV tumours without pre-irradiation, all other arms are closed when group (1) is closed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary brain tumor: gliomas (low or high grade), intracerebral meningiomas, pituitary adenomas, craniopharyngioma and other rare brain tumors or
- •brain tumor recurrence without pre-irradiation or
- •brain tumor recurrence with pre-irradiation > 40 Gy in the overlap region with the recurrence region
- •indication for radiotherapy or radiochemotherapy
- •Both proton and photon therapy are possible from a medical point of view (that is no standard indication for protons or standard indication for example one-time stereotaxy
- •age >= 18 years
- •general condition ECOG ≤ 2, outpatient basis possible
- •indication for high dose (except group 4) radiotherapy or radiochemotherapy
- •capacity to consent and present written informed consent
排除标准
- •lack of capacity to consent or lack of written consent
- •cerebral lymphomas
- •brain metastases
- •very small tumors (for example acoustic neuromas, very small recurrences) for this is a proton therapy from a medical point of view no alternative to a stereotactic radiotherapy
- •inability to MRI planning (eg. contraindications to performing MRI)
- •lack of compliance of the patient
- •lack of or limited possibility of a reproducible storage (eg by severe restriction of mobility of the patient)
- •missing or limited possibility of regular follow-up visits in accordance with the study protocol
结局指标
主要结局
late toxicity as cumulative measure
时间窗: 1 year (or at least 6 months)
Events for the endpoint are: 1. any late toxicity CTCAE 4.0 ≥ grade II (except pre-existing conditions) 2. decrease in Quality of life (EORTC-QLQ-C30 and BN20) by \>10% 3. decrease in brain function (MOCA test) by more than 10%
次要结局
- Local tumour control(1 year and 2 years)
- Overall survival(1 year and 2 years)
- late toxicity as cumulative measure(2 years)
- Acute toxicity(3 months after treatment)
研究者
Mechthild Krause
Principal Investigator
Technische Universität Dresden